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Clinical study of gefitinib monotherapy versus gefitinib combined with bevacizumab for advanced NSCLC with positive EGFR 21L858R mutation

Clinical study of gefitinib monotherapy versus gefitinib combined with bevacizumab for advanced NSCLC with positive EGFR 21L858R mutation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032720
Enrollment
Unknown
Registered
2020-05-08
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR 21L858R mutation positive for advanced NSCLC

Interventions

experimental group:Gefitinib combined with bevacizumab
control group:Gefitinib monotherapy

Sponsors

Ya'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, and the use of NGS detection suggested an exon mutation in EGFR 21L858R. 2. There were measurable lesions according to RECIST 1.1. 3. The investigators determined that stage IIIB (intolerance to radiotherapy) and stage IV (including asymptomatic brain metastases) required targeted therapy, including patients with recurrence or progression after initial treatment or chemotherapy. 4. Aged >= 18 years, male or female. 5. ECOG physical state score is 0 ~ 2. 6. Serum hemoglobin >= 100g/L, platelet >= 10 x 10^9/L, neutrophil absolute count >= 1.5 x 10^9/L. 7. Serum creatinine = 60 mL/ min. 8. Serum bilirubin <= 1.5 times UNL, AST (SGOT) and ALT (SGPT) <= 2.5 times UNL, alkaline phosphatase <= 5 times UNL. 9. Normal coagulation function (PT extension no more than 3s, APTT extension no more than 10s) 10. The patients signed a formal informed consent to demonstrate their understanding that the study was consistent with the hospital's policy and ethical requirements.

Exclusion criteria

Exclusion criteria: 1. Squamous cell or carcinoid carcinoma of the lung. 2. NGS detection suggested simultaneous combination of EGFR 19del deletion, EGFR18, and 20 exon mutations. 3. Have received other targeted drugs or immunotherapy. 4. Pregnant or lactating women. 5. Patients with mental disorders or unable to obtain valid data through regular follow-up.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Adverse reactions;

Secondary

MeasureTime frame
Overall survival;Objective remission rate;The quality of life;

Countries

China

Contacts

Public ContactTao Liu

Ya'an People's Hospital

15892680693@163.com+86 15892680693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026